TABLE XII

List of Excipients in JPED 2007 and Maximum Amount Specified per Route

Excipient	Intravenous Injection	Intramuscular Injection	Subcutaneous Injection	Other Injection Routes
2-Phenoxyethanol		2.8 mg	2.8 mg
4-(2-Hydroxyethyl)-1-piperazine ethanesulfonic acid	6 mg
Acacia		25 mg
Acetic acid	20 mg	20 mg	q.s.^*
Acetyltryptophan	461 mg
Albumin	10 mg
alpha-Thioglycerol	25 mg	25 mg	25 mg
Aluminium chloride		1.5 mg	1.5 mg
Aluminum hydroxide		1 mg	1 mg
Aluminum monostearate				20 mg
Aluminum potassium sulfate		4.4 mg	4.4 mg
Ammonia water	q.s.
Ammonium acetate		2.3 mg
Anhydrous citric acid	0.2 g	10 mg		6 mg
Anhydrous ethanol	1 mL	1.6 mL	1.5 mL
Anhydrous stannous chloride	2 mcg
Ascorbic acid	2.8 g	1.68 g	10 mg	Local anesthetic (50 mg)
Asepsis sodium bicarbonate	80 mg
Benzalkonium chloride		1.8 mg	1 mg	0.4 mg
Benzethonium chloride	0.02 mg	1 mg		5 mg/mL
Benzoic acid	44 mg	44 mg
Benzyl alcohol	0.5 mL	0.5 mL	0.5 mL	Intraspinal, intracutaneous, local anesthetic
Benzyl benzoate		371 mg
Butyl p-hydroxybenzoate				Local anesthetic (2 mg)
Butylhydroxyanisol	75 mcg			Intra-arterial
Calcium disodium edetate	30 mg		0.09 mg	Intra-arterial, intraspinal
Calcium D-saccharate	237.1 mg
Calcium gluconate	20 mg	20 mg	20 mg
Calcium oxide	1.08 mg
Camellia oil		1 mL	1 mL
Carbazochrome sodium sulfonate	0.5 mcg/kg/min
Carmellose sodium		50 mg	15 mg	Intracutaneous
Castor oil		0.02 mL
Chlorobutanol	600 mg	60 mg	500 mg
Citric acid	882 mg	137.5 mg	113.4 mg	Intra-arterial
Concentrated glycerin	12.5 g	80 mg	80 mg
Creatinine	160 mg	128 mg	20 mg	Intracutaneous
Cresol	20 mg	20 mg	158.2 mg
Cysteine hydrochloride	16.8 mg	16.8 mg
Dextran 40	120 mg	5.01 mg		Intra-arterial
Dextran 70			3 mg
Dibasic potassium phosphate	11.6 mg	6.92 mg	6.92 mg
Dibasic sodium citrate	16.8 mg
Dibasic sodium phosphate	816 mg	480 mg	294.5 mg	Intra-arterial, intraspinal, intracutaneous, local anesthetic
Dibutylhydroxytoluene	0.09 mg	26 mcg
Diethanolamine	12 mg
Diethylenetriaminepentaaceitc acid	8 mg
Dilute hydrochloric acid	26.25 mcL	12 mcL	12 mcL	Local anesthetic
Disodium edetate	16 mg			Intra-arterial
Disodium hydrogen phosphate anhydrous	875 mg	90 mg	90 mg	Intra-arterial
DL-Methionine		30 mg	1 mg	Intra-arterial, intracutaneous
D-Mannitol	3200 mg	500 mg	210 mg	Intra-arterial, intracutaneous
Dried aluminum hydroxide Gel		0.47 mg	0.47 mg
Dried sodium carbonate	512 mg	72 mg	20 mg
Dried sodium sulfite	1 g	0.48 g	0.48 g	Local anestetic
D-Sorbitol	12 g	800 mg	250 mg	Other
D-Sorbitol solution		50 mg	50 mg	Other
Ethanol	800 mg	0.15 mL	2 mg
Ethyl lactate		0.1 mg
Ethyl oleate		Trace amount		Intracutaneous
Ethyl p-hydorxybenzoate		2.5 mg
Ethylenediamine	30 mg		30 mg
Ethylurea	3 mg	3 mg
Ferric chloride	0.2 mg
Fluorescein sodium				Other
Formalin			0.05 mg
Fructose	900 mg
Gelatin		0.1 mg	1 mg	Other
Gentisylethanolamide	100 mg
Glacial acetic acid	25 mg	25 mg	37.5 mg
Glucose	8 g	528 mg	300 mg	Intracutaneous, local anesthetic
Glycerin	60 mg	60 mg	48 mg	Other
Glycine	2250 mg	2700 mg	160 mg	Intracutaneous
Glycyl glycine	3.102 mg/kg
Heparin sodium	2000 U
Highly purified yolk lecithin	36 mg
Human serum albumin	800 mg	30 mg	5 mg	Intra-arterial, intraspinal
Hydrochloric acid	0.256 mL	30 mcL	30 mcL	Intra-arterial, intraspinal, intracutaneous, local anesthetic
Hydrolyzed gelatin	40 mg		6.25 mg
Hydroxypropylcellulose		25 mg
Inositol	50 mg	60 mg
Isotonic sodium chloride solution	q.s.	q.s.	q.s.	Intra-arterial, intracutaneous
Lactic acid	214.5 mg	36 mg	34 mg	Other
Lactic acid glycolic acid copolymer (1:1)			14.2 mg
Lactic acid glycolic acid copolymer (95:5) (high molecular weight copolymer)			6.175 mg
Lactic acid glycolic acid copolymer (95:5) (low molecular weight copolymer)			18.525 mg
Lactose monohydrate	1250 mg	193.8 mg	96.9 mg	Intra-arterial, intracutaneous
Lactose, microcrystalline cellulose spheres
L-Alanine	160 mg	40 mg
L-Arginine	3240 mg	3240 mg	20 mg
L-Arginine hydrochloride	120 mg	20 mg	20 mg
L-Aspartic acid	16 mg	8 mg
L-Cysteine	8 mg
L-Cystine	35 mg
L-Histidine	624 mg	1.07 mg/kg	0.012 mg/kg
L-Histidine monohydrochloride	50 mg
Lidocaine	40 mg	2.5 mL
Lidocaine hydrochloride		320 mg
L-Leucine		20 mg	20 mg
L-Lysine hydrochloride	8 mg		0.05 mg
L-Lysine L-glutamate	600 mg
L-Methionine
L-Phenylalanine	10 mg	10 mg		Intra-arterial
Macrogol 300	4875 mg/m²
Macrogol 35000
Macrogol 400	3.2 g	3.2 g	3.2 g	Local anesthetic
Macrogol 4000	120 mg	180 mg	40 mg	Other
Macrogol 600	300 mg
Magnesium chloride	213.6 mg
Magnesium gluconate	869 mg
Magnesium sulfate	50 mg	15 mg	1 mg	Local anesthetic
Maleic acid		2 mg
Maleic anhydride	20 mg
Maltose	10 g	441 mg	441 mg	Intracutaneous
m-Cresol	30 mg	6 mg	30 mg	Intracutaneous
Medium chain fatty acid triglyceride	360 mg/kg
Meglumine	15.4 g
Meprylcaine hydrochloride	0.04 mg	200 mg	200 mg
Methanesulfonic acid		q.s.	q.s.
Methyl p-hydroxybenzoate	30 mg	25 mg	25 mg	Intracutaneous, local anesthetic
Monobasic potassium phosphate	350 mg	350 mg	350 mg	Intracutaneous
Monoethanol amine	2.3 mg
Monopotassium L-glutamate monohydrate			0.48 mg
Monosodium L-glutamate monohydrate	600 mg	400 mg	400 mg
Myristoyl gamma-picolynium chloride		0.6 mg		Intracutaneous
N,N-dimethylacetamide	300 mg
N-hydroxyethyl lactamide solution	8571.4 mg
Nicotinamide	250 mg	250 mg	75 mg	Other
Oleic acid	4.8 mg
Peanut oil		q.s.
Peptone, casein			0.025 g/mL
Phenol	64 mg	64 mg	50 mg	Intracutaneous
Phenol red			0.02 mg
Phosphoric acid	69.3 mg	69.3 mg	35 mg
Polyoxyethylene (160) polyoxypropylene (30) glycol	10 mg	10 mg		Intracutaneous
Polyoxyethylene castor oil	4.68 g
Polyoxyethylene hydrogenated castor oil	400 mg
Polyoxyethylene hydrogenated castor oil 50	500 mg	500 mg	500 mg
Polyoxyethylene hydrogenated castor oil 60	9600 mg	500 mg	500 mg	Intraspinal
Polyoxyethylene sorbitan monolaurate	80 mg	60 mg	60 mg
Polysorbate 20	40 mg		0.1 mg
Polysorbate 80	500 mg	100.2 mg	50 mg	Intracutaneous
Potassium chloride		0.1 mg	0.1 mg
Potassium pyrosulfite	1250 mg	6 mg	6 mg
Potassium sulfate				Local anesthetic
Potassium thiocyanate	5 mg
Powdered acacia		40 mg	12.5 mg
Procaine hydrochloride		4 mg
Propyl p-hydroxybenzoate	4 mg	2.4 mg	4.2 mg	Intracutaneous, local anesthetic
Propylene carbonate
Propylene glycol	3.32 g	0.5 mL	0.5 mL	Intraspinal
Protamine sulfate			3.5 mg
Pullulan
Purified gelatin	200 mg	640 mg	2.5 mg	Intra-arterial
Purified oleic acid	-
Purified olive oil	200 mg
Purified soybean lecithin	1.2 g
Purified soybean oil	500 mg
Purified yolk lecithin	6 g
Sesame oil	30 mg	300 mg	300 mg	Other
Sodium acetate	111.39 mg	14 mg	15 mg	Other
Sodium acetate, anhydrous		1.64 mg
Sodium acetyl tryptophan	536.5 mg		215 mg
Sodium benzoate	40 mg	20 mg		Intracutaneous
Sodium bicarbonate	1.75 g	2.3g	2.3g	Intraspinal, intracutaneous
Sodium bisulfite	1250 mg	150 mg	150 mg	Intracutaneous, local anesthetic
Sodium borate
Sodium bromide	10 mg	10 mg	10 mg
Sodium caldiamide	240 mg
Sodium caprylate	332.5 mg		135 mg
Sodium carbonate	28.5 mg/kg	20.8 mg	20.8 mg
Sodium carbonate, Anhydrous	968 mg	932 mg		Intracutaneous
Sodium chloride	9 g	700 mg	540 mg	Intra-arterial, intraspinal, intracutaneous, local anesthetic
Sodium chondroitin Sulfate	9.8 mg
Sodium citrate	1764 mg	112 mg	100 mg	Intra-arterial, intraspinal, intracutaneous
Sodium desoxycholate	41 mg			Intraspinal, intracutaneous
Sodium dihydrogen phosphate anhydrous	80 mg	70 mg		Other
Sodium dihydrogen phosphate dihydrate	164 mg	91 mg	75 mg	Intra-arterial, intraspinal
Sodium dihydrogen phosphate dihydrate	0.0206 mg	125.5 mg	125.5 mg	Intra-arterial, intraspinal, intracutaneous
Sodium dihydrogen phosphate monohydrate	0.11 mg/kg		0.78 mg	Intracutaneous
Sodium formaldehydesulfoxylate	16 mg	16 mg		Intraspinal
Sodium gluconate	57 mg	57 mg
Sodium hydroxide	600 mg	300 mg	230 mg	Intra-arterial, intracutaneous, local anesthetic
Sodium lactate solution	50 mg
Sodium L-tartrate	40 mg
Sodium metasulfobenzoate	0.2 mg	0.2 mg		Other
Sodium monohydrogen phosphate heptahydrate	4.105 mg	0.0425 mg/kg (body weight)	7.56 mg
Sodium oleate	2.16 mg/kg
Sodium pyrophosphate, anhydrous	32 mg	32 mg		Intraspinal
Sodium pyrosulfite	60 mg	60 mg	60 mg	Intracutaneous, local anesthetic
Sodium salicylate	600 mg	100 mg	100 mg
Sodium sulfite	60 mg
Sodium thioglycolate	20 mg	20 mg	20 mg
Sodium thiomalate		2.5 mcg
Sodium thiosulfate	3 mg	4 mg	4 mg
Sorbitan esters of fatty acid	37.5 mg
Sorbitan sesquioleate	50 mg	50 mg
Soybean oil	300 mg
Stannous chloride	400 mcg
Succinic acid	2 mg
Sucrose	39.84 g		25 mg
Sulfuric acid	q.s.	87.6 mg		Intra-arterial
Tartaric acid	20 mg	8 mg
Taurine	40 mg	40 mg
Thimerosal	12 mg	12 mg	12 mg
Thioglycolic acid	2.5 mg	2.5 mg	2.5 mg
Trehalose	3.6 mg/kg
Tribasic sodium phosphate, sodium phosphate tribasic, trisodium phosphate	32 mg	32 mg	32 mg
Triethanolamine	30 mg
Trometamol	266.20 mg	2.44 mg	2.4 mg	Intra-arterial, intraspinal, intracutaneous
Urea	50 mg	40 mg	50 mg
Ursodeoxycholic acid	14 mg
Water for injection	4000 mL	40 mL	40 mL	Intra-arterial, intraspinal, intracutaneous, local anesthetic
White soft sugar			50 mg
Xylitol	200 mg	90 mg		Others
Zinc acetate			0.12 mg
Zinc chloride		6.25 mg	0.42 mg
Zinc chloride solution			0.356 mg
Zinc oxide			0.192 mg

↵* q.s. = quantity sufficient.